NCT Number: NCT07727135
People with chest pain are often tested for a heart attack using a blood test called high-sensitivity cardiac troponin (hs-cTn). Traditionally, this blood test is repeated 3 hours after the first sample. Newer guidelines recommend repeating the test after 1 hour instead, which may allow patients to receive a diagnosis and leave the hospital sooner.
The purpose of the DanRUSH trial is to compare these two strategies: repeating the blood test after 1 hour versus after 3 hours in adults with suspected acute coronary syndrome. The study will evaluate whether the 1-hour strategy is as safe as the 3-hour strategy while reducing the length of hospital stay.
DanRUSH is a nationwide, pragmatic, cluster-randomized trial conducted in emergency- and cardiology departments across Denmark. The results will help determine the best timing for blood testing in patients with suspected heart attack and improve future care for these patients.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Aalborg University Hospital, Aalborg, Denmark
Each year, approximately 80,000 individuals present to the Danish healthcare system with chest pain. Of these, around 25,000 are admitted to hospital and approximately 8,000 are diagnosed with acute myocardial infarction. High-sensitivity cardiac troponin (hs-cTn) is the cornerstone biomarker for the diagnosis of myocardial infarction and is essential for the rapid rule-in and rule-out of acute coronary syndromes. Because the diagnosis of myocardial infarction relies not only on troponin concentration but also on changes in troponin levels over time, serial blood sampling is required to distinguish acute myocardial injury from chronic elevations.
Advances in hs-cTn assay sensitivity have enabled progressively shorter intervals between serial blood sampling. Traditionally, most emergency departments have used a 0/3-hour algorithm, in which hs-cTn is measured at presentation and again after 3 hours. However, contemporary European guidelines recommend accelerated diagnostic pathways using a 0/1-hour or 0/2-hour algorithm.
The primary purpose of the DanRUSH trial is to determine whether shortening the interval between serial hs-cTn measurements from 3 hours to 1 hour is both safe and effective in adults presenting with suspected acute coronary syndrome.
The primary safety endpoint is defined as the risk of new (missed or recurrent) myocardial infarction or cardiovascular death after dischage from the index hospitalization -of the 0/1-hour algorithm compared with the 0/3-hour algorithm. Efficacy will be assessed as hospital length of stay, defined as the time from presentation to discharge. The study aims to demonstrate that the 0/1-hour algorithm is non-inferior to the 0/3-hour algorithm with respect to safety while improving efficiency through shorter hospital stays.
The study is designed as a nationwide, pragmatic, open-label, stepped-wedge cluster randomized trial. Participating emergency- and cardiology departments in Denmark will sequentially and randomly transition from the conventional 0/3-hour hs-cTn algorithm to the 0/1-hour hs-cTn algorithm until all sites are exposed to the intervention. A study-specific order set in the electronic medical record will ensure the correct timing of serial blood sampling and facilitate identification of study participants. Relevant baseline and outcome information will be obtained from routinely collected data in the electronic medical record and Danish nationwide health registries.
The results of DanRUSH are expected to provide definitive randomized evidence regarding the safety and effectiveness of the 0/1-hour hs-cTn algorithm. If the accelerated diagnostic strategy is shown to be safe, it may support broader implementation and improve patient flow by reducing unnecessary hospital stays. Conversely, if safety cannot be confirmed, the study may prevent widespread adoption of an insufficiently validated diagnostic strategy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
High-sensitivity cardiac troponin measurements obtained at presentation and 3 hours after the initial sample as part of the conventional diagnostic strategy for suspected acute coronary syndrome.
High-sensitivity cardiac troponin measurements obtained at presentation and 1 hour after the initial sample as part of the accelerated diagnostic strategy for suspected acute coronary syndrome.
Time frame: From discharge from the index hospitalization until 30 days after discharge.
The risk of new (missed or recurrent) myocardial infarction or cardiovascular death after dischage -of the 0/1-hour algorithm compared with the 0/3-hour algorithm.
Time frame: During the index hospitalization (from emergency department presentation until hospital discharge)
Length of stay, defined as the time from presentation to the emergency department until discharge from hospital.
Time frame: From discharge from the index hospitalization until 12 months after discharge.
New myocardial infarction within 12 months following discharge from the index hospitalization, excluding myocardial infarction diagnosed during the index hospitalization.
Time frame: 30 days and 12 months following discharge
Death from any cause following discharge from the index hospitalization
Time frame: 30 days and 12 months following discharge
Occurrence of myocardial infarction during follow-up
Time frame: During the index hospitalization, at 30 days, and at 12 months after the index presentation
Performance of diagnostic coronary angiography following the index presentation
Time frame: During the index hospitalization, at 30 days, and at 12 months after the index presentation
Invasive coronary treatment, including percutaneous coronary intervention or coronary artery bypass grafting.
Time frame: 30 days and 12 months following discharge
Presentation to the emergency department or hospital following discharge from the index hospitalization
Time frame: 30 days and 12 months following discharge
Hospital admission following discharge from the index hospitalization
Time frame: From emergency department presentation until initiation of treatment, assessed during the index hospitalization (up to 7 days)
Time from presentation to initiation of relevant treatment for acute coronary syndrome
Contact information is provided by the study sponsor or research team.
Herlev and Gentofte Hospital
Other
Danish Randomized Trial of Rapid or Ultra-rapid Diagnosis of Myocardial Infarction Using High-Sensitivity Cardiac Troponin on Hospital Presentation
Acronym: DanRUSH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05336435
Acute Coronary Syndrome, Angina Pectoris
Aabenraa, Denmark
View Trial DetailsNCT03583047
Acute Coronary Syndrome, Cardiovascular Diseases
Mexico City, Mexico
View Trial DetailsNCT03419325
Acute Coronary Syndrome, Arterial Occlusive Diseases
Carolina, Puerto Rico
View Trial DetailsNCT04475380
Acute Coronary Syndrome, Angina Pectoris
Enschede, Netherlands
View Trial Details